GSK face more legal action over antidepressant drug
Source: Drug Research
06/09/2004 - GlaxoSmithKline (GSK) is facing a number of US lawsuits, which claims the company had covered up negative data that indicated its antidepressant Paxil might increase suicidal tendencies in young people.
The action, instigated by the families of children and teenagers who were prescribed Paxil, known as Seroxat in the UK and Europe, comes after a legal confrontation with New York Attorney General Eliot Spitzer, who last month sued the firm over the disclosure of research suggesting problems with the drug in children.
GlaxoSmithKline, which are Europe’s biggest drug maker, agreed to pay $2.5m (£1.37m) in damages to settle the case, and promised to publish all research in the future. They denied any wrongdoing.
A spokesman for GSK said that data had been made available in various forms, as was normal practice, via journals, presentations at scientific meetings and in letters to healthcare professionals.
He added that GSK had also submitted all the trial data to regulatory authorities.
It was in 2002 that the company first became embroiled in a row over the safety of the antidepressant Seroxat, which to this day remains unresolved. Indeed the pharmaceutical industry has been criticized for keeping quiet about negative results from clinical trials, since bad publicity would make product marketing more difficult.
In 2002, more than two million prescriptions for Paxil/Seroxat were written for American children and adolescents alone, worth $55m in sales.
Paxil, which is sold as Seroxat in Europe, used to be GSK's biggest selling product. But the medicine has declined in importance following the arrival of cheap generic versions of the drug in the United States.
Last month’s settlement was seen by many as a victory for GSK as the company could have lost hundreds of millions had the case gone to court.